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A specialty pharmaceutical company focused on infectious diseases. Frukostpresentation 21 mars på IVA. Presenting team. Charlotte Edenius VP R&D Projects. Bertil Samuelsson CSO . Rein Piir CFO / IR. 2. Flying Start to 2011 . Recent news flow highlights - PowerPoint PPT Presentation
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Corporate presentation, [ ] 2011NOT FOR DISTRIBUTION IN THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, SINGAPORE OR SOUTH AFRICA
A specialty pharmaceutical company focused on infectious diseases
Frukostpresentation 21 mars på IVA
Presenting team
Charlotte EdeniusVP R&D Projects
Rein PiirCFO / IR
Bertil SamuelssonCSO
2
3
Flying Start to 2011 Recent news flow highlights• Dec-10 Private placement of SEK 280m (EUR 30m)
• Feb-11 Phase 1a start with TMC649128 HCV/POL
• Feb-11 Joint venture with Janssen Pharmaceutica on Dengue Fever
• Feb-11 Global Phase 3 studies start with TMC435 in treatment naïve patients
• Feb-11 Global Phase 3 study starts with TMC435 in treatment experienced relapser patients
• Feb-11 Japanese Phase 3 studies start with TMC435 in treatment naïve and in treatment experienced patients
• Feb-11 C205 (PILLAR) Interim SVR24 data in treatment naïve patients
• Mar-11 Launch of Xerese™ in US
Key Innovation and Commercialisation at Medivir
Xerclear® / Xerese™ - in global launch phase 2011• First step towards becoming a profitable research-based pharmaceutical company• Differentiated product profile - unique indication text • Significant blue-chip marketing partners.
TMC 435 - Potentially best in class hepatitis C drug• Strong safety profile – no adverse events over SoC in P2b• Excellent antiviral activity in P2b PILLAR and ASPIRE studies• High convenience – one pill, once daily, no food interactions• Global Phase 3 trials started recently
Strong Pipeline in development• A strong pipeline of innovative infectious disease drug
candidates in development with leading pharma partners• World class expertise in polymerase and protease drug targets and drug development
4
Strong Pipeline with Multiple Paths to Value Creation
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Key programmes in our early stage pipeline
Cathepsin K inhibitors for bone disorders – MIV-710/711
Creating value for shareholders by developing products further under own management
• This class of inhibitors intervene in disease states where there is excessive bone loss, e.g. osteoporosis, osteoarthritis and metastatic bone disease
• Estimated combined global market opportunity in excess of USD 12 billion
• Cathepsin K inhibitor program• Maintain the beneficial bone formation, in
contrast to other anti-resorptives• Furnish potent and long duration of activity• A low once daily human efficacious dose at 50
mg QD estimated• Strong IP position
Disease and market MIV-710 and MIV-711
Upcoming events in 2011
• Two Candidate Drugs selected, CD 1(MIV-710) and CD2 (MIV-711), which are progressing in preclinical development studies
• Start of phase 1 clinical trials for MIV-711 expected in Q3 2011
7
Dengue Fever Joint Venture with Janssen Pharmaceuticals
In February 2011 Medivir signed a co-development collaboration with Janssen Pharmaceuticals N.V. focused on dengue virus • Strengthens Medivir’s presence in infectious diseases
• Utilises strong know-how in the discovery of protease inhibitor drugs• Approach focussed on inhibition of the dengue NS3 protease involved in viral replication
Commercial strategy• Both parties are contributing 50:50 resources to the research program
• Increased potential upside from co-development deal
Market opportunity• Dengue virus infection is a major problem in subtropical regions where the incidence has
increased 30-fold over the last 50 years
• Up to 50 million infections occur annually in more than 100 endemic countries and the annual death rate from dengue infection is approximately 30,000
• This growing prevalence has not been met by any significant advances in treatment1
1 World Health Organisation, Fact sheet N°117, March 2009.
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Our hepatitis C franchisePartnered and in-house product portfolio
TMC435 – The Leading Next Generation Protease Inhibitor
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• Excellent anti-viral efficacy shown in Phase 2b PILLAR and ASPIRE studies
• Convenient: one pill and once daily, no food interactions
• Strong safety profile: no adverse events over SoC in the Phase 2b PILLAR and ASPIRE studies
Hepatitis C - A blockbuster potential market
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• Globally ~180 million (3-4% of world population) infected with hepatitis C virus, of which 80% develop chronic disease
• The difficult to treat genotype 1 (G1a/b) account for ~70% of the HCV population– Sustained viral response (SVR) in G1 patients is very low, 42-48% on PegIFNα/RBV, SoC
• Approximately 12 million HCV infected in the US, Europe and Japan– Prevalence in JPN ~1.9 million with ~55% being diagnosed (~25% worldwide)– Health care burden in the US ~ 5 BUSD / year
• Estimated market value of over USD 10 billion in 2015 and increasing• Treatment-experienced patients, currently ~ 0.5 million, comprise ~half of the market value
The Hepatitis C Market
Market Value
TMC 435 potential
• Analysts estimate TMC435 annual peak sales of 2-4 BUSD
HCV Clinical Pipeline
TMC435 – major commercial opportunity• EUR 80.5 million deal value
• EUR 30 million outstanding• Medivir retain Nordic rights
• Prevalence of chronic HCV infected ~115,000
• Current annual treatment rates ~ 3,150
TMC435 – summary status• Potent HCV NS3/4A protease inhibitor • Backbone of future DAA combination
therapies• Data expected 2011/12
• Long patent life• IP extending to 2026 and 2028
• Global Phase 3 trials ongoing• Regulatory filings expected in 2013
12
HCV Clinical Pipeline
TMC649 (HCV Pol) - major commercial opportunity
• EUR 147 million deal value• EUR 95 million outstanding
• Medivir retain Nordics rights• Prevalence of chronic HCV infected
~115,000• Current treatment rates ~ 3,150
TMC649 (HCV Pol) – summary status• Nucleoside/tide NS5B inhibitor• An ideal DAA agent for future TMC435
combination regimens• High barrier to resistance and broad
genotype coverage• Long patent life
• IP extending to 2027 and 2029• Phase 1 trails ongoing
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Evolution of the HCV therapy
% S
VR
24, c
ure
rate
s
Hepatitis C PI – the competitive landscape
15
• Combinations of DAA agents:─ Telaprevir in phase 2a in combination with VX-222 (NNRTI) +/- SoC─ Danoprevir in phase 2a in combination with R7128 (NI) +/- SoC─ BMS-650032 in phase 2a in combination with BMS-790052 (NS5A inh) +/- SoC─ GS-9256 in combination with GS-9190 (NNRTI) +/- Ribavarin
Note: nanoprevir and ABT-450 require ritonavir-boosting
HCV PI’s in combination with DAAs and SoC
Phase 1a Phase 1b Phase 2a Phase 2b Phase 3 Registration
TelaprevirVX-950
BoceprevirSCH-503034
DanoprevirR-7227?
BI201335 ?
TMC435
Vaniprevir ?MK-7009
PHX1766
IDX320
ABT-450VPY-376 ACH-1625
MK-5172
BMS-650032
GS-9256
Narlaprevir?
HCV Nucleosides & Nucleotides – Competitive landscape
Pre-clin Phase 1 Phase 2a Phase 2b Phase 3
PSI-7977Pharmasset
R-7128Roche/Pharmasset
PSI-938Pharmasset
TMC649128
IDX-184Idenix
INX-189Inhibitex
RG-7348Roche/Ligand
MK-0608Merck
R-1626Roche/
NM-283Novartis
Stopped, or underreview
Medivir
TMC435 Late Stage Clinical Trial Programme
PILLAR (C205) – 386 genotype-1 infected treatment-naïve patients
DRAGON (C215) – 92 genotype-1 infected treatment-naïve patients
ASPIRE (C206) – 462 genotype-1 infected treatment-experienced patients
Phase 2b studies
QUEST 1 (C208) 375 genotype-1 infected treatment-naïve patients
QUEST 2 (C216) 375genotype-1 infected treatment-naïve patients
PROMISE (C3007) 375 genotype-1 infected relapsed patients
Phase 3 studies started in Japan both in naïve and treatment experienced
genotype-1 infected patients
Phase 3 studies
For additional information on inclusion and exclusion criteria for these studies, please see www.clinicaltrials.gov
17
Follow Up Phase Recently Initiated
TMC435 Phase 2b: study design & findings - 48 week interim analysis
18
• TMC435-C205 is a global phase 2b study in 386 genotype-1 treatment-naïve patients
• Once daily (q.d.), 75 mg and 150 mg, of TMC435 + SoC:- 12-week triple therapy followed by SoC alone up
to week 24- 24-week triple therapy
• Response-guided treatment duration in TMC435 arms- End treatment at Week 24, ifo HCV RNA <25 IU/mL detectable or undetectable at
Week 4, ando HCV RNA <25 IU/mL undetectable at Weeks 12, 16,
and 20- All other patients continued Peg/RBV for up to 48
weeks
PILLAR (C205)
Planned interim analysis
PILLAR C205 week 48 interim analysis – safety and efficacy
1. Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus
2. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 243. Potent and consistent antiviral efficacy was demonstrated with SVR24 rates of up to 84%4. No clinically relevant difference in safety and tolerability between TMC435 and placebo groups
19
Sustained Virological Response 4 and 24 Weeks after Planned End of Treatment (EoT); % (n/ N)
TMC435 12PR24 75mg q.d. N=78
TMC435 24PR24 75mg q.d. N=75
TMC435 12PR24 150mg q.d. N=77
TMC435 24PR24 150mg q.d. N=79
Placebo N=77
SVR4 SVR24
87.2 (68/ 78) 83.6 (61/ 73)
86.5 (64/ 74) 76.1 (51/ 67)
84.9 (62/ 73) 83.1 (59/ 71)
88.5 (69/ 78) 84.4 (65/ 77)
71.2 (42/ 59) N/ A
* < 25 log10 IU/mL undetectable q.d.: once daily, PR: pegIFNalpha-2A and ribavirin, SVR4 and SVR24: patients with undetectable HCV RNA 4 and 24 weeks after planned EoT, respectively. N/A: Patients in the control arm continue SoC until Week 48 and SVR24 data was not available
TMC 435 Phase 2b study design
20
• TMC435-C206 is a global phase 2b study in 462 genotype-1 treatment-experienced patients
• Once daily (q.d.), 100 mg and 150 mg, of TMC435 + SoC:- 12-week triple therapy followed by 36 weeks of SoC- 24-week triple therapy followed by 24 weeks of SoC- 48-week triple therapy
ASPIRE (C206)
Antiviral efficacy in TMC435 ASPIRE C206 - 24-week interim dataTMC12/PR48100 mg (N=66)
TMC24/PR48100 mg (N=65)
TMC48/PR48100 mg (N=66)
TMC12/PR48150 mg (N=66)
TMC24/PR48 150 mg (N=68)
TMC48/PR48 150 mg
(N=65)
Pbo48/PR48
(N=66)
HCV RNA <25 IU/mL undetectable, % (n/N)
Overall population Week 4 (RVR)
67.7 (44/65)***
59.4 (38/64)***
53.8 (35/65)***
63.1 (41/65)***
70.8 (46/65)***
66.2 (43/65)*** 1.5 (1/65)
Prior null responder 33.3 (5/15) 50.0 (8/16) 25.0 (4/16) 35.3 (6/17) 41.2 (7/17) 41.2 (7/17) 0.0 (0/16)
Prior partial responder 65.2 (15/23) 40.9 (9/22) 60.9 (14/23) 65.2 (15/23) 69.6 (16/23) 68.2 (15/22) 0.0 (0/23)
Prior relapser 88.9 (24/27) 80.8 (21/26) 65.4 (17/26) 80.0 (20/25) 92.0 (23/25) 80.8 (21/26) 3.8 (1/26)
Overall population Week 24
87.1 (54/62)***
84.5 (49/58)***
85.2 (52/61)***
85.7 (54/63)***
90.8 (59/65)***
90.3 (56/62)*** 51.9 (28/54)
Prior null responder 71.4 (10/14) 83.3 (10/12) 68.8 (11/16) 70.6 (12/17) 81.3 (13/16) 93.3 (14/15) 44.4 (4/9)
Prior partial responder 86.4 (19/22) 80.0 (16/20) 85.7 (18/21) 86.4 (19/22) 90.9 (20/22) 86.4 (19/22) 19.0 (4/21)
Prior relapser 96.2 (25/26) 88.5 (23/26) 95.8 (23/24) 95.8 (23/24) 96.3 (26/27) 92.0 (23/25) 83.3 (20/24)
***Statistically significant difference versus placebo, p<0.001
• The TMC435 treatment arms demonstrate high response rates• The antiviral efficacy was enhanced in all patient groups through week 12 and 24• Notably, the null responder group demonstrated significant response rates
Excellent antiviral activity
• TMC435 was generally safe and well tolerated consistent with the previously reported phase 2b PILLAR C205 study
• Significant decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups
• The two most frequently reported AEs were fatigue and headache, with comparable results shown in the placebo group
TMC435 was safe and well tolerated
% All TMC435N = 396
PlaceboN = 66
Fatigue 41 42
Headache 33 33
Safety and Tolerability in TMC435 ASPIRE C206 24-week interim data
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Phase 3 trial design: Quest-1, Quest-2* and PROMISE
Post Therapy FU
Time(weeks)
TMC435 150mg+ SoC; 1-12 w
SoC
12 24 48 72
Post Therapy FU 48w SoC
12w triple + 12 SoC
Quest 2* – patients in this trial will either receive Pegasys® and Copegus®) or PegIntron® and Rebetol® as part of their treatment
Approximately 1125 patients in total, 375 in each studyResponse-guided treatment duration in TMC435 arms
• End treatment at Week 24 if predefined stop criteria are met• All other patients continue on Peg/RBV for up to 48 weeks
• SoC
• Quest-1, Quest-2:• will evaluate a single once-daily oral tablet of TMC435 (150 mg) verses placebo in
treatment naïve HCV patients • PROMISE:
• will evaluate a single once-daily oral tablet of TMC435 (150 mg) verses placebo in HCV patients who experienced viral relapse after previous interferon-based therapy
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Conclusion
Expected key newsflow highlights during 2011• Apr-11 EASL - additional data on TMC435
• Q211 TMC435, 48-week interim data from the phase 2b C206 (ASPIRE) trial in treatment-experienced patients
• Q3-11 C205 (PILLAR) full SVR24 data
• Q3-11 Start of phase 1 trials with MIV-711
• H2-11 Start of phase 3 trials with TMC435 in treatment-experienced non- responder patients
• H2-11 Phase 1a/1b results with TMC649
• Q4 AASLD – additional data on TMC435
• Q4-11 OTC launch of Xerclear® in Europe by GSK
• Q4-11 C206 (ASPIRE) SVR24 data
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Upcoming News Flow